Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin (Mix2Mix)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 30

Study type: Observational

Funder types: Industry

Identifiers

NCT00775736

BIASP-3665

Details and patient eligibility

About

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

Enrollment: 611 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus

Exclusion criteria

• Known or suspected allergy to study product or related products.
• Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.

Trial design

611 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 50

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 30